So how big is Amazon-Berkshire-JPM anyway?

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Lots of legal kerfuffles in the health IT world as the federal shutdown drags on in Washington. Here’s what we’re tracking:

— So how big is Amazon-Berkshire-JPM anyway? Not that big, claim the troika in a legal defense that erupted earlier this month.

— A new product label needed for AI in health: A group of experts says companies selling AI-based diagnostic aids should rethink how they explain their products to clinicians.

— EHR reports lead to subpoenas: Attempts by a hospital's clinicians to flag risks in EHR systems have landed them subpoenas.

eHealth Tweet thread of the day: Chris Dwan@fdmts Medical records are such an incredible mess that they barely qualify as data. AI / ML don’t fix dirty, incoherent, incorrect data. Neither does blockchain. Misaligned structures and incentives in the business of medicine dug this hole. That’s where we must fix it.

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Driving the Day

SO HOW BIG IS AMAZON-BERKSHIRE-JPM ANYWAY? — The mysterious health venture launched by Amazon, Berkshire Hathaway and JPMorgan Chase claims that it’s not a major threat to other health companies because it has no products and, furthermore, is only serving its own employees. At least, that’s according to a legal defense that emerged as part of an employment dispute between health data giant Optum and an erstwhile company exec, David Smith, who jumped ship to the new initiative in the closing days of 2018.

Optum alleges that Smith, during a drawn-out departure, misappropriated trade secrets (including printing power point presentations with confidential data) and is in violation of the non-compete, -disclosure, and -solicitation clauses of his employment contract. Smith (via his personal lawyers) is trying to move the dispute into arbitration in a motion filed Wednesday, and claims that there’s no misappropriated information anyway.

A NEW PRODUCT LABEL FOR AI IN HEALTH? — A working group convened by Duke’s health policy center says a few things must change before AI is widely adopted as part of clinical decision support, including product labeling. Companies’ ability to explain how the algorithms work, and how they’ve been trained, will significantly impact how regulators and clinicians view the risk they pose, experts wrote in a new report. A few other takeaways:

— We need to know more about clinical decision support in general: We don’t know enough yet about when CDS is most useful, or whether CDS should be proactive instead of simply nudging clinicians to reconsider their decisions, experts wrote.

— AI-based CDS might need a new payment model: Though ideally diagnostic aids would lower costs, we don’t know enough about when public and private payers are likely to cover such AI-based products and services.

— The FDA needs to explain its stance: Experts called on the agency to clarify whether it will examine a product’s "explainability" or "interpretability" — how transparent the product or company is about how the system makes decisions and what they mean — when evaluating in the AI-enabled Software as a Medical Device category.

RHODE ISLAND DOCS ALARMED BY SUBPOENAS — Process servers in recent days have delivered subpoenas charging doctors at a Providence hospital with medical misconduct — mistakes reported by the clinicians themselves that didn't injure any patients but were meant to draw attention to risks in their EHR system, our Arthur Allen reports.

The episode has upset the doctors and their colleagues, who say the state health department's punitive response could frustrate voluntary reporting of medical errors, one of the leading causes of death in the United States. EHR safety researchers concur, saying that penalizing doctors for self-reported mistakes like this sends the wrong message.

The subpoenas, sent to at least four emergency room doctors at Rhode Island Hospital, deal with X-rays and other scans mistakenly ordered by the doctors. Such errors are common because EHR screens are complex, and it's easy to click on the wrong icon or patient name, say experts on EHRs.

"Anyone punishing individual providers for these events is punishing the wrong thing," says Jason Adelman, chief patient safety officer at New York-Presbyterian Hospital. "These are system issues, not the provider being reckless. The focus should be on things like EHR usability and safety."

President Donald Trump, White House counselor Kellyanne Conway, National Economic Council Director Larry Kudlow and Lance Leggitt, deputy director of the Domestic Policy Council were among attendees, as were HHS Secretary Alex Azar, Labor Secretary Alex Acosta and Joe Grogan, who leads health policy at OMB and is soon to head the Domestic Policy Council.

One attendee, Jamesia Shutt of Aurora, Colo., received a bill for about $16,000 after an emergency room visit, lobbyists and outside sources told POLITICO. Brad Lerner, a primary care physician from Sarasota, Fla., experienced out-of-network surprise billings from pathology and radiology departments in his own hospital.

IN CONGRESS

SENSENBRENNER, ROBY TO LEAD REPUBLICANS ON JUDICIARY PANELS — Reps. Jim Sensenbrenner of Wisconsin and Martha Roby of Alabama will lead Republicans on two of House Judiciary’s tech-related panels, our Tech colleague John Hendel reports.

Sensenbrenner will take the ranking spot on the Regulatory Reform, Commercial and Antitrust Law Subcommittee, which is poised to scrutinize tech industry consolidation under chair David Cicilline (D-R.I.).

Sensenbrenner is known for his outspoken stance during past fights over reining in government surveillance. He sponsored the USA Freedom Act, designed to block the intelligence community from collecting millions of Americans’ phone records every day. Roby, meanwhile, will be GOP ranking member on the Courts, Intellectual Property and the Internet Subcommittee

WICKER TALKS PRIVACY WITH FORMER FTC OFFICIALS — Senate Commerce Chairman Roger Wicker(R-Miss.) convened a closed-door meeting Wednesday for panel members and aides to discuss data privacy with three former FTC commissioners, John reports.

The three officials were Jon Leibowitz, a former Democratic FTC chairman; former Democratic Commissioner Julie Brill; and Maureen Ohlhausen, a Republican who served as acting agency chair under President Donald Trump.

Wicker’s panel is in the midst of assembling draft privacy legislation aimed at installing safeguards to police tech giants like Facebook and Google. Senators are developing the draft in the wake of last year’s scandal involving misuse of Facebook users’ data by Trump campaign-linked data firm Cambridge Analytica. The FTC is currently investigating Facebook over this matter, although the probe is stalled amid the shutdown.

The former FTC officials now have employers with stakes in the privacy fight. Leibowitz co-chairs the 21st Century Privacy Coalition, funded by ISPs supportive of federal legislation that overrides state laws. Brill is now deputy general counsel for Microsoft and has written blog posts about the company's support for national privacy legislation.

DIRECTTRUST MESSAGES UP 63 PERCENT — Health information exchange nonprofit DirectTrust, which uses the Direct message protocol, says there were about 274 million Direct message transactions in 2018, up 63 percent since 2017. The number of patients whose data were involved in those transactions was 248,000, up about 35 percent since 2017.

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